Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, 10 63-ro Yeongdengpo-gu, Seoul, 07345, Korea.
Division of Endocrinology and Metabolism, Department of Internal Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, 363 Dongbaekjukjeon-daero Giheung-gu, Yongin-si, Gyeonggi-do, 16995, Korea.
BMC Endocr Disord. 2022 Apr 11;22(1):99. doi: 10.1186/s12902-022-01010-w.
The co-occurrence of diabetes and osteoporosis is common in postmenopausal women. For the treatment of postmenopausal osteoporosis, current guidelines recommend initial treatment with bisphosphonates, but it is unclear whether bisphosphonates provide a similar degree of therapeutic efficacy in patients with diabetes. This study sought to compare the efficacy of monthly oral ibandronate for retaining bone mineral density (BMD) in diabetic and non-diabetic postmenopausal women with osteoporosis.
Postmenopausal osteoporotic women with or without diabetes were enrolled in this study from three hospitals in an open-label approach from 2018 to 2020. Each group of patients received oral ibandronate 150 mg once monthly for 1 year. BMD, trabecular bone score (TBS), serum C-terminal telopeptide of type I collagen (CTx) and procollagen type 1 N-terminal propeptide (P1NP) were evaluated prospectively. Treatment-emergent adverse events and changes in glucose metabolism during drug use were also monitored.
Among the 120 study participants, 104 (86.7%) completed the study. Following 1 year of treatment, BMD increased by 3.41% vs. 3.71% in the lumbar spine, 1.30% vs. 1.18% in the femur neck, and 1.51% vs. 1.58% in the total hip in the non-diabetes and diabetes groups, respectively. There were no significant differences in BMD changes between the groups, and the differences in CTx or P1NP changes between groups were not significant. We did not observe any significant differences in baseline TBS values or the degree of change between before and after 1 year of ibandronate treatment in either group in this study. A total of 11 adverse events (9.2%) that recovered without sequelae occurred among the 120 included patients, and there was no significant difference in the frequency of adverse events between the groups (p = 0.862). The changes in fasting glucose and glycated hemoglobin levels between before and after treatment were not significant in the diabetic group.
Bisphosphonate therapy showed similar increases in BMD and decreases in CTx and P1NP of postmenopausal women with and without diabetes. Monthly oral ibandronate can be a safe and effective therapeutic option in postmenopausal osteoporosis patients with type 2 diabetes.
NCT number: NCT05266261, Date of registration: 04 March 2022.
糖尿病和骨质疏松症在绝经后妇女中同时发生较为常见。对于绝经后骨质疏松症的治疗，目前的指南建议初始治疗采用双膦酸盐，但尚不清楚双膦酸盐在糖尿病患者中是否具有相似的治疗效果。本研究旨在比较每月口服伊班膦酸钠对糖尿病和非糖尿病绝经后骨质疏松症妇女保留骨密度（BMD）的疗效。
本研究采用开放标签的方式，于 2018 年至 2020 年期间从三家医院招募绝经后骨质疏松症伴或不伴糖尿病的女性患者。每组患者均接受每月口服伊班膦酸钠 150mg，连续 1 年。前瞻性评估 BMD、骨小梁评分（TBS）、血清 I 型胶原 C 端肽（CTX）和前胶原 1 N 端前肽（P1NP）。还监测了治疗中出现的不良事件和药物使用期间葡萄糖代谢的变化。
在 120 名研究参与者中，有 104 名（86.7%）完成了研究。经过 1 年的治疗，非糖尿病组腰椎骨密度增加 3.41%，股骨颈增加 1.30%，全髋增加 1.51%；糖尿病组分别增加 3.71%、1.18%和 1.58%。两组间 BMD 变化无显著差异，CTX 或 P1NP 变化也无显著差异。在本研究中，两组基线 TBS 值或治疗 1 年后前后变化程度均无显著差异。120 例纳入患者中共有 11 例（9.2%）出现无后遗症的不良事件，两组间不良事件的发生率无显著差异（p=0.862）。治疗后糖尿病组空腹血糖和糖化血红蛋白水平的变化无显著差异。
双膦酸盐治疗可使绝经后伴或不伴糖尿病的女性患者的 BMD 增加，CTX 和 P1NP 降低。每月口服伊班膦酸钠可作为 2 型糖尿病绝经后骨质疏松症患者的一种安全有效的治疗选择。
NCT05266261，注册日期：2022 年 3 月 4 日。
